Designs, delivers and evaluates Oracle Argus database and other PRA safety systems training for global Safety & Risk Management (SRM), and/or Drug Safety / Pharmacovigilance staff to meet corporate goals and to improve upon safety information collection. Ensures that training is delivered in accordance with regulatory requirements and corporate policies.
Support other relevant global pharmacovigilance systems and related business processes as need to enhance efficiency and provide training support.
•6+ years relevant industry experience (CRO or pharmaceutical)
o Advanced knowledge in Pharmacovigilance and the regulatory environment governing safety and risk management activities.
o Substantial pharmaceutical or CRO experience including project leadership and management, preferred.
•3-5 years of experience in working with Oracle Argus Safety Database System
•3-5 years of experience in Training and/or Quality positions, desired
o Experience in the design, delivery, and evaluation of training courses or programs. Working knowledge of training management software, preferred.
•An undergraduate degree or its international equivalent from an accredited institution. Focus area in in clinical, science, or health-related field.
o An advanced degree in education, organizational development, business, clinical, science or health-related or its international equivalent, preferred.
•Read, write, and speak fluent English; fluent in host country language required.
•Up to 40-50% travel required for this position (mainly domestic); travel to be heaviest during first six months.
This role will report to one of the following offices:
U.S: Raleigh, NC; Charlottesville, VA; Blue Bell, PA (greater Philadelphia area); greater Chicago, IL area; or greater Boston, MA area
Europe: Reading, UK or Mannheim, Germany.
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.